NCT01576107

Brief Summary

Impact of a 4-week exercise intervention vs. a stress-management-training on physical activity (measured objectively and by questionnaire) of cancer patients of different entities and out-patient regimes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

7 months

First QC Date

April 5, 2012

Last Update Submit

April 22, 2014

Conditions

Cancer

Keywords

Different cancer entities

Outcome Measures

Primary Outcomes (1)

  • Physical activity (accelerometer, Actigraph)

    measured for 7 days

    4 weeks

Secondary Outcomes (6)

  • physical activity (Short QUestionnaire to ASsess Healthenhancing physical activity, SQUASH)

    4 weeks, 3 months

  • Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)

    4 weeks, 3 months

  • Quality of life (EORTC QLQ C30)

    4 weeks, 3 months

  • variables of the Health Action Process Approach

    4 weeks, 3 months

  • Barriers and barrier management in physical exercise

    4 weeks, 3 months

  • +1 more secondary outcomes

Study Arms (2)

Physical activity

EXPERIMENTAL

Exercise counseling (behavior change techniques)

Other: Exercise counseling (behavior change techniques)

Stress-management

EXPERIMENTAL

Stress-management training

Other: Stress-management training

Interventions

Exercise counseling (behavior change techniques)OTHER

4-week exercise intervention for cancer patients of different entities and out-patient regimes.

Physical activity
Stress-management trainingOTHER

4-week stress-management-training for cancer patients of different entities and out-patient regimes.

Stress-management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physical activity \< 150 minutes /week
  • Patients are currently receiving outpatient treatment (acute or maintenance therapy) or finished this therapy not longer than six months ago

You may not qualify if:

  • Serious Orthopedic limitations
  • Serious neurological disorders
  • Serious cardiovascular diseases
  • Bone metastases
  • wound healing / scarring not completed
  • Rehabilitation during the next eight weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Center for Tumor Diseases (German Cancer Research Center)

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

National Center for Tumor Diseases

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (1)

  • Ungar N, Wiskemann J, Sieverding M. Physical Activity Enjoyment and Self-Efficacy As Predictors of Cancer Patients' Physical Activity Level. Front Psychol. 2016 Jun 21;7:898. doi: 10.3389/fpsyg.2016.00898. eCollection 2016.

    PMID: 27445882DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joachim Wiskemann, Dr.

    German Cancer Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 12, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2012

Study Completion

May 1, 2013

Last Updated

April 23, 2014

Record last verified: 2014-04

Locations

DE(2)